[The bioequivalence of a new allopurinol tablet formulation in comparison to a reference formulation].
An investigation of the bioequivalence of a new allopurinol formulation with 300 mg allopurinol (CAS 315-30-0, allo 300 von ct) was performed in a two-way cross-over study with 18 subjects. The relative bioavailability with respect to a reference preparation for AUC related to oxipurinol was 98.1% and for Cmax 91.7%. A positive decision for bioequivalence derived from the usual confidence intervals for both parameters related to allopurinol and the metabolite oxipurinol, respectively, tmax showed no difference regarding oxipurinol. The new formulation was bioequivalent to the reference.
Metzner
J E
JE
Galmed GmbH, Gesellschaft für galenische und medizinische Forschung, Halle/Saale.
Buchberger
D
D
Läuter
J
J
Pech
R
R
D000328:Adult; D000493:Allopurinol / Q000008:administration & dosage / Q000493:pharmacokinetics*; D000963:Antimetabolites / Q000008:administration & dosage / Q000493:pharmacokinetics*; D019540:Area Under Curve; D018592:Cross-Over Studies; D005260:Female; D006801:Humans; D008297:Male; D010117:Oxypurinol / Q000097:blood / Q000493:pharmacokinetics; D013810:Therapeutic Equivalency
D000963:Antimetabolites; D000493:Allopurinol; D010117:Oxypurinol
Untersuchungen zur Bioäquivalenz einer neuen Allopurinol-Tablettenformulierung im Vergleich zu einer Referenzformulierung.